MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. HARMONIC ACE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problems Device Inoperable (1663); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2016

Event Type  malfunction  

Event Description

Upon initial testing before the start of surgery, a pair of harmonic ace shears failed to work.The instrument would not spin.A replacement device was tested and successfully used.This event did not affect patient care.The shears in question were returned to stryker.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5825357
• MDR Text Key: 50528863
• Report Number: 5825357
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HAR36
• Device Lot Number: 4544837
• Other Device ID Number: LAPAROSCOPIC 5MM DIAMETER SHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1